BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    CARE

    DI: 08809822510559 · Model: 29 XL Vanilla · CARE LATEX INTERNATIONAL US INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CARE
    Primary DI
    08809822510559
    Version / Model
    29 XL Vanilla
    Company Name
    CARE LATEX INTERNATIONAL US INC
    Labeler DUNS
    134211144
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-04-21
    Public Version
    1
    Public Version Date
    2025-04-29
    Public Version Status
    New
    Public Device Record Key
    108dc55e-ffe1-4720-ae93-7c730e88d110
    Distribution End Date
    2025-04-21

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HIS Condom

    GMDN Terms

    Code Name
    45138 Basic male condom, Hevea-latex

    Identifiers

    Type ID
    Primary 08809822510559

    Premarket Submissions

    Submission Number Supplement Number
    K994311 000